Pain, ShoulderNCT05358730
Effects of IASTM in the Treatment of Adhesive Capsulitis
A study testing Standard Exercise, Instrument Assisted Soft Tissue Mobilization (IASTM) and Home Exercise in people with Pain, Shoulder and Adhesion; Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain
- What is being tested?
- Standard Exercise, Instrument Assisted Soft Tissue Mobilization (IASTM) and Home Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 30 and 65 years;
- Duration of complaint of more than three months
- ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions
Who cannot join
- Having cervical radiculopathy
- Thoracic outlet syndrome
- Rheumatological disorders
- Fractures or tumors of either upper extremity
- Corticosteroid injections in the affected shoulder within the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
Official title: Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients with Adhesive Capsulitis
This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.
Read the detailed description
Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.
- Conditions
- Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain
- Being tested
- Standard Exercise, Instrument Assisted Soft Tissue Mobilization (IASTM), Home Exercise
- Keywords
- Adhesive capsulitis, Function, Pain, Exercise
- Medical subject headings
- Shoulder Pain, Tissue Adhesions, Facial Pain, Bursitis, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ExerciseOther
Glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises were performed under the supervision of a physiotherapist two days per week for six weeks at the clinical setting (Celik and Kaya Mutlu, 2016).
Instrument Assisted Soft Tissue Mobilization (IASTM)Other
IASTM treatment was applied to the posterior-anterior-middle deltoid, latissimus dorsi, teres major, teres minor, supraspinatus and infraspinatus muscle fibers, superficial and deep fascia. IASTM was applied in parallel and vertical direction to the muscle fibers treated with the instrument at a 45° angle, each technique (SWEEP, BRUSH (straight short steps) techniques) for 20 seconds (Ikeda, Otsuka, Kawanishi, and Kawakami, 2019). It was performed two days per week for six weeks.
Home ExerciseOther
Hme exercise program consisted of glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises.
It was asked to perform two days per week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| IASTM + Standard Exercise Group | Experimental | Patients were applied IASTM in combination with standard exercise program two days a week for six weeks. The IASTM technique was performed using six titanium-plated instruments in different sizes, shapes and treatment styles. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. Receives: Other: Standard Exercise; Other: Instrument Assisted Soft Tissue Mobilization (IASTM); Other: Home Exercise |
| Standard Exercise Group | Active comparator | Patients were given a standard exercise program two days a week for six weeks. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. Receives: Other: Standard Exercise; Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity function
DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.
Measured: Baseline
Secondary outcomes (14)
Upper extremity function
DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.
Measured: At the end of the 3-week intervention
Upper extremity function
DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.
Measured: At the end of the 6-week intervention
The severity of pain
The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that "0" number shows "no pain" and "10" number shows "most excruciating pain" on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line.
Measured: Baseline
The severity of pain
The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that "0" number shows "no pain" and "10" number shows "most excruciating pain" on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line.
Measured: At the end of the 3-week intervention
The severity of pain
The severity of pain that people feel on their shoulders at rest, during activity and at night was evaluated using the Visual Analogue Scale (VAS). The patients were told that "0" number shows "no pain" and "10" number shows "most excruciating pain" on the visual analog scale, and the participant was asked to position the pain feeling in this range by drawing a line.
Measured: At the end of the 6-week intervention
Functional level of shoulder
The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score.
Measured: Baseline
Functional level of shoulder
The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score.
Measured: At the end of the 3-week intervention
Functional level of shoulder
The modified constant shoulder score assesses pain, position, daily living activities, ROM and strength. Scoring consists of pain (15 points), daily activities (20 points), active range of motion (AROM) (40 points) and strength (25 points). The total Constant score is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Turkish validity and reliability study of modified constant score.
Measured: At the end of the 6-week intervention
Range of motion
Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees.
Measured: Baseline
Range of motion
Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees.
Measured: At the end of the 3-week intervention
Range of motion
Shoulder flexion, abduction, internal rotation and external rotation ROM were actively and passively measured using a universal goniometer while the participant was in the supine position. All shoulder ROMs were repeated 3 times and the average of the angular values obtained was recorded in degrees.
Measured: At the end of the 6-week intervention
Health-related quality of life
In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates "bad health", 100 indicates "good health". In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form.
Measured: Baseline
Health-related quality of life
In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates "bad health", 100 indicates "good health". In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form.
Measured: At the end of the 3-week intervention
Health-related quality of life
In order to evaluate the quality of life, the Short Form-36 (SF-36) was used, which consists of 36 items evaluating 2 main (physical and mental component) and 8 sub-parameters (physical, emotional and social function, physical role, mental health, pain, general health and vitality). The scale evaluating the score of each subgroup between 0-100; 0 indicates "bad health", 100 indicates "good health". In our study, SF-36 health control scale scoring was calculated on the internet address http://www.rand36calculator.com with the percentage values given as a result of marking the answers in the form.
Measured: At the end of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start10 Mar 2019
- Primary completion10 Aug 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ShoulderStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Aydın University
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci, PT, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358730
- Sponsor's protocol ID
- 1008
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients with Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05358730
- Acronym / sponsor ID
- 1008
- Conditions
- Pain, Shoulder, Adhesion; Shoulder, Myofacial Pain
- Keywords
- Adhesive capsulitis, Function, Pain, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istanbul Aydın University
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.
Detailed description
Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM + Standard Exercise Group | Experimental | Other: Standard Exercise, Other: Instrument Assisted Soft Tissue Mobilization (IASTM), Other: Home ExercisePatients were applied IASTM in combination with standard exercise program two days a week for six weeks. The IASTM technique was performed using six titanium-plated instruments in different sizes, shapes and treatment styles. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. |
| Standard Exercise Group | Active comparator | Other: Standard Exercise, Other: Home ExercisePatients were given a standard exercise program two days a week for six weeks. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 30 and 65 years;
- Duration of complaint of more than three months
- ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions
Key exclusion criteria (5 listed)
- Having cervical radiculopathy
- Thoracic outlet syndrome
- Rheumatological disorders
- Fractures or tumors of either upper extremity
- Corticosteroid injections in the affected shoulder within the previous 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ExerciseGlenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises were performed under the supervision of a physiotherapist two days per week for six weeks at the clinical setting (Celik and Kaya Mutlu, 2016). | Other | IASTM + Standard Exercise Group, Standard Exercise Group |
| Instrument Assisted Soft Tissue Mobilization (IASTM)IASTM treatment was applied to the posterior-anterior-middle deltoid, latissimus dorsi, teres major, teres minor, supraspinatus and infraspinatus muscle fibers, superficial and deep fascia. IASTM was applied in parallel and vertical direction to the muscle fibers treated with the instrument at a 45° angle, each technique (SWEEP, BRUSH (straight short steps) techniques) for 20 seconds (Ikeda, Otsuka, Kawanishi, and Kawakami, 2019). It was performed two days per week for six weeks. | Other | IASTM + Standard Exercise Group |
| Home ExerciseHme exercise program consisted of glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises. It was asked to perform two days per week for six weeks. | Other | IASTM + Standard Exercise Group, Standard Exercise Group |
Primary outcome
Upper extremity function
Time frame: Baseline
DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.
14 secondary outcomes
Upper extremity function
Time frame: At the end of the 3-week intervention
Upper extremity function
Time frame: At the end of the 6-week intervention
The severity of pain
Time frame: Baseline
The severity of pain
Time frame: At the end of the 3-week intervention
The severity of pain
Time frame: At the end of the 6-week intervention
Functional level of shoulder
Time frame: Baseline
Functional level of shoulder
Time frame: At the end of the 3-week intervention
Functional level of shoulder
Time frame: At the end of the 6-week intervention
Range of motion
Time frame: Baseline
Range of motion
Time frame: At the end of the 3-week intervention
Range of motion
Time frame: At the end of the 6-week intervention
Health-related quality of life
Time frame: Baseline
Health-related quality of life
Time frame: At the end of the 3-week intervention
Health-related quality of life
Time frame: At the end of the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tansu Birinci, PT, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise, Instrument Assisted Soft Tissue Mobilization (IASTM) and Home Exercise in people with Pain, Shoulder and Adhesion; Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity function (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.